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Sponsored by: |
Procter and Gamble |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00384046 |
The purpose of this study is to examine whether the transdermal testosterone system (TTS) is effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women who are on transdermal estrogen.
Condition | Intervention | Phase |
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Hypoactive Sexual Desire Disorder |
Drug: Testosterone Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 24-Week Study to Evaluate the Efficacy/Safety of Transdermal Testosterone in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen Therapy. |
Estimated Enrollment: | 300 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | March 2008 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
300mcg/day testosterone
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Drug: Testosterone
patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks
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2: Placebo Comparator
Placebo arm
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Drug: Placebo
patch, placebo, patch changed every 3-4 days, 24 weeks
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This is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, 24 week study to be conducted in approximately 300 patients at approximately 14 clinical sites in the UK, 6 sites in Australia, 5 sites in Germany, and 2 sites in Canada. Women will be randomised 1:1 to receive 300 mcg/day TTS or placebo for a 24 week period. Consistent with previous phase III studies, efficacy will be assessed over 24 weeks using the Sexual Activity Log (SAL), and at 12 and 24 weeks using the Profile of Female Sexual Function (PFSF) and Personal Distress Scale (PDS). Safety will be assessed over the entire 24 weeks. Hormone data (free and total testosterone, total estradiol, and sex hormone binding globulin) will be collected at Weeks -4 and 24. The total duration of treatment for each patient is 24 weeks.
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, New South Wales | |
Research Facility | |
Gordon, New South Wales, Australia, 2072 | |
Research Facility | |
Ashfield, New South Wales, Australia, 2131 | |
Research Facility | |
Randwick, New South Wales, Australia, 2031 | |
Australia, South Australia | |
Research Facility | |
Dulwich, South Australia, Australia, 5065 | |
Australia, Victoria | |
Research Facility | |
Prahran, Victoria, Australia, 3181 | |
Australia, Western Australia | |
Research Facility | |
Nedlands, Western Australia, Australia, 6009 | |
Botswana, DEU | |
Research Facility | |
Freiburg, DEU, Botswana, D-79085 | |
Canada, Quebec | |
Research Facility | |
Quebec City, Quebec, Canada, G1S 2L6 | |
Research Facility | |
Montréal, Quebec, Canada, H1T 1P6 | |
Germany | |
Research Facility | |
Hamburg, Germany, 20357 | |
Research Facility | |
Aachen, Germany, D-52074 | |
Research Facility | |
Münster, Germany, 48149 | |
United Kingdom | |
Research Facility | |
Salford, United Kingdom, M8 8HD | |
Research Facility | |
Coventry, United Kingdom, CV7 8LA | |
Research Facility | |
London, United Kingdom, NW8 9NH | |
Research Facility | |
Doncaster, United Kingdom, DN1 2ET | |
Research Facility | |
Atherstone, United Kingdom, CV9 1EU | |
Research Facility | |
London, United Kingdom, W2 1NY | |
Research Facility | |
Leicester, United Kingdom, LE1 5WW | |
Research Facility | |
Lichfield, United Kingdom, WS14 9LH | |
Research Facility | |
London, United Kingdom, W12 0HS | |
Research Facility | |
Leicester, United Kingdom, LW1 5WW | |
Research Facility | |
London, United Kingdom, SW1W 8RH | |
Research Facility | |
Warks, United Kingdom, CV9 1EU | |
Research Facility | |
London, United Kingdom, SE1 9RT | |
Research Facility | |
London, United Kingdom, W1G 7JW | |
Research Facility | |
Plymouth, United Kingdom, PL4 8QU | |
Research Facility | |
Headington, United Kingdom, OX3 9DU | |
Research Facility | |
Herts, United Kingdom, SG6 4TS | |
United Kingdom, Oxford | |
Site Facility | |
Headington, Oxford, United Kingdom, OX3 9DU | |
United Kingdom, West Midlands | |
Research Facility | |
Solihull, West Midlands, United Kingdom, B91 2JL |
Study Director: | Imran A Lodhi, MD | Procter and Gamble |
Responsible Party: | Procter and Gamble Pharmaceuticals ( Imron Lodhi, MD ) |
Study ID Numbers: | 2005108 |
Study First Received: | October 3, 2006 |
Last Updated: | February 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00384046 History of Changes |
Health Authority: | Canada: Health Canada; United States: Food and Drug Administration |
Sexual Dysfunctions, Psychological Estrogens Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Methyltestosterone Dyskinesias Hormones Testosterone 17 beta-cypionate |
Signs and Symptoms Anabolic Agents Testosterone Mental Disorders Neurologic Manifestations Hypokinesia Menopause Androgens |
Sexual Dysfunctions, Psychological Disease Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Methyltestosterone Hormones Sexual and Gender Disorders Dyskinesias |
Pharmacologic Actions Testosterone 17 beta-cypionate Signs and Symptoms Anabolic Agents Testosterone Pathologic Processes Mental Disorders Therapeutic Uses Neurologic Manifestations Hypokinesia Androgens |